Return to RCRIM Teleconference Minutes and Agendas
Meeting Information
HL7 RCRIM Agenda
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Date: 2011-08-30
Time: 10:00-11:00 am Eastern Time
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| Facilitator
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Ed Tripp
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Note taker(s)
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Ed Tripp
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| Attendee
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Name
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Affiliation
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| x |
Becky Angeles |
ScenPro
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| x |
Michael Brennan |
Johnson and Johnson
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| x |
Joel Finkle |
Image Solutions, Inc.
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| x |
Patricia Garvey |
FDA
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| x |
Ed Helton |
NCI
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| x |
Joyce Hernandez |
Merck
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| x |
Jay Levine |
FDA
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| x |
Andrew Marr |
Marr Consultancy Ltd
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| x |
Armando Oliva |
FDA
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| x |
Steve Sandberg |
ScenPro
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| x |
John Speakman |
NCI
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| x |
Ed Tripp |
Edward S. Tripp and Associates
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| x |
Steve Ward |
Lilly
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| Quorum Requirements Met: YES
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quorum for RCRIM is 10 plus a co-chair
Agenda
Agenda Topics
- Agenda review and approval
- Approve meeting minutes from 2011-06-07_RCRIM_Call_Minutes
- Approve SWOT Analysis
- Publication Request Needed
- HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” balloted in 2011 May
- HL7 Version 3 Domain Analysis Model: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” from 2009 January
- HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Design R1” from 2011 May
- HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 “ from the 2011 May
- Ballot Reconcilation Needed
- CDISC2MSG Study Design DAM from 2009 May
- Review WGM Agenda
- Other Items
Supporting Documents
RCRIM SWOT from 2011-08-02
Minutes
Minutes/Conclusions Reached:
- Agenda review and approval
- Agenda was accepted as presented
- Approve meeting minutes from 2011-06-07_RCRIM_Call_Minutes
- Minutes unanimously approved
- Approve SWOT Analysis
- Motion by Steve Ward, seconded by Ed Helton to approve the SWOT analysis
- Affirmative: 11
- Opposed: 0
- Abstain: 1
- Motion Carries
- Publication Request Needed
- HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” balloted in 2011 May
- Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
- HL7 Version 3 Domain Analysis Model: Regulated Studies; CDISC Content to Message - Study Participation, Release 1” from 2009 January
- Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
- HL7 Version 3 Implementation Guide: Regulated Studies; CDISC Content to Message - Study Design R1” from 2011 May
- Patty Garvey will discuss with Mitra Rocca. Material will be reviewed at the WGM
- HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 “ from the 2011 May
- Armando will discuss with Norman Gregory. Material will be reviewed at WGM
- Ballot Reconcilation Needed
- Patty Garvey and Mead Walker are meeting with the team this week to discuss ballot reconcilation on Subject Data. A decission on how best to move forward will be considered at the WGM
- CDISC2MSG Study Design DAM from 2009 May
- Patty Garvey and Mead Walker will discuss recomendations and questions raised by BRIDG harmonization. A determination on how to proceed with this ballot will be determined by the results of this discussion.
- Review WGM Agenda
- No changes were made to the agenda
- Other Items
- None
- Adjourned 10:25 am Eastern.
Meeting Outcomes
| Action Item
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Owner
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Due Date
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| CDISC to Message team will prepare publication requests and recomendation on ballot reconcilation for the WGM |
Patty Garvey |
9/13/2011
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Next Meeting Preliminary Agenda Items
- Agenda review and approval
- Approve meeting minutes from 2011-08-30_RCRIM_Call_Minutes
- Action items from WGM
- Other Items
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